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FDA Guidance for Industry: Format and Content of the Microbiology Section of an Application

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075101.pdf

Content:
Antimicrobial drugs differ from other classes of drugs in that they are intended to affect microbial, rather than patient, physiology. For this reason, the technical reports of in vivo and in vitro effects on microorganisms are critical for establishing effectiveness.

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